Metabolic Effects of Chronic Ketosis (KETO-CHF Metabolic)

Heart Failure Clinical Trial

Official title:

Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Metabolic Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05161676
• Other study ID #: KETO-CHF Metabolic
• Status: Completed
• Phase: Phase 2
• Start date: December 15, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Heart Failure (HF) is a major public health issue because the disease affects 1-2% of the Western population and the lifetime risk of HF is 20%. Despite major improvements in the management and care of patients with HF, the 1-year mortality in patients with HF is 13% and >50% of HF patients are admitted during a 2.5 year period. Furthermore, patients with HF have markedly decreased physical capacity and quality of life. Thus, there is a need for new treatment modalities in this group of patients.

It is well established that patients with heart failure have metabolic disturbances, including disturbed glucose metabolism with increasing insulin resistance, increased lipolysis, and disturbances in skeletal muscle homeostasis.

Presently there are no data on the clinical metabolic effects of long-term oral ketone-supplementation in patients with chronic HF.

In this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on endogenous protein, glucose, and fatty acid metabolism in patients with HFrEF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic heart failure with NYHA II-III

• Left ventricular ejection fraction =40%

• Negative urine-HCG for women with childbearing potential

Exclusion Criteria:

• Known diabetes or HbA1c =48 mmol/mol

• Significant cardiac valve disease

• Severe stable angina pectoris

• Age <18 years

Related Conditions & MeSH terms

• Heart Failure

Intervention

Dietary Supplement:
• Ketone monoester
Commercially available ketone supplement
• Placebo drink
Isocaloric placebo

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in lipolysis rate	Measured as differences in palmitate flux	14 days of dietary supplement
Secondary	Changes in protein metabolism	Measured with a urea tracer	14 days of dietary supplement
Secondary	Changes in glucose kinetic	Measured by glucose tracer	14 days of dietary supplement